Senior Embedded Software Engineer with experience in software design for Medical Devices required by high-growth medical devices company in Galway.
From its headquarters in Galway, my client designs highly sophisticated medical devices for global markets. Due to expansion in global markets, they are growing their design team yet again.
Collaborating with a cross-functional team, you will conduct product design and development in accordance with CE & FDA regulations for medical device design and manufacture for global markets.
- BEng or equivalent in Electronic/Software Engineering
- 10+ years Embedded software/design experience
- Proficient in C/C++ programming
- Experience in Embedded Software design for medical devices is CRITICAL
- Working knowledge IEC/EN 62304 Medical Device Software (Software Lifecycle Processes) and FDA guidance documentation
- Experience of software development related to verification and validation for medical electrical equipment
- Proficiency in software design for 8/16/32 bit Microchip microprocessors using Embedded C
- Experience using graphical frameworks for embedded targets, such as Qt
- Knowledge of low power analog & digital circuits including interfacing with Microcontrollers such as SPI, I2C, UART, ADCs etc
- Familiar with interfacing of wireless communication modules (Bluetooth, LoRa etc.)
- Experience in creating the software deliverables for medical device new product development
- Familiar with software development tools such as Visual Studio, MPLAB X, Compilers, ICD etc.
- Working knowledge of Software Configuration Management tools (Bitbucket or similar) and Software Issue Tracking tools (JIRA or similar)
- Strong interpersonal skills with the ability to collaborate in a multi-disciplinary team
- Self-directed with effective time-management skills
- Flair for innovation
- Ability to document engineering evolution, development and testing using MS Office Applications such as Word, Excel, PowerPoint etc.
- Collaborate as a member of cross-functional project teams in developing products from concept through to commercialization
- Conduct product design and development in accordance with CE & FDA regulations relating to medical device design and manufacture
- Conduct product design in accordance with the project objectives with due consideration of project schedule, budget, risks, regulatory submission, standard compliance
- Conduct use and design risk assessment, implementing controls or mitigations to reduce risk levels
- Conduct and record proof of principle testing of prototypes to confirm feasibility of ideas and concepts
- Engage with clinicians and product users in their clinical setting to elicit user need/functional requirements
- Prepare technical documentation in clear and concise terms in accordance with good engineering practice
- Liaise closely within R&D, Science, Manufacturing, Operations, Quality, Sales and Marketing functions through the product development lifecycle
- Maintain current working knowledge of the key international standards, regulations and regulatory guidance direction that govern the medical devices industry including medical electrical equipment